SOLIFENACINE SUCCINATE

Product NDC
69097-259
11-digit product format
690970259
Labeler code
69097
Product ID
69097-259_13de71d6-5be1-49ee-b2cf-e3d7c8fd7b45
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
solifenacine succinate
Dosage form
TABLET
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA209839
Marketing category
ANDA
Marketing start
2019-05-20
Marketing end
0000-00-00
Substance
SOLIFENACIN SUCCINATE
Active strength
5 mg/1
Pharmacologic classes
Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-259-02EA - Each69097-2596f8bebf0-6e8e-4ada-9e71-263c3863cb5812019-06-19
69097-259-05EA - Each69097-259d01f0987-bfeb-4a3d-91d9-25a66a83df0b12019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-259SOLIFENACINE SUCCINATE TABLET [CIPLA USA INC.]3Legacy NDC20221208_74d4f207-2a8c-47e6-81f4-1b52f5e35b99.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-259-026909702590230 TABLET in 1 BOTTLE (69097-259-02) 30 tablet2019-05-200000-00-00NoNoCurrent
69097-259-056909702590590 TABLET in 1 BOTTLE (69097-259-05) 90 tablet2019-05-200000-00-00NoNoCurrent
69097-259-15690970259151000 TABLET in 1 BOTTLE (69097-259-15) 1000 tablet2019-05-200000-00-00NoNoCurrent